Betnovate 1 mg/g cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Betnovate 1 mg/g cutaneous solution

Betamethasone 17-valerate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Betnovate 1 mg/g cutaneous solution is and what it is used for
2. What you need to know before using Betnovate 1 mg/g cutaneous solution
3. How to use Betnovate 1 mg/g cutaneous solution
4. Possible side effects
5. How to store Betnovate 1 mg/g cutaneous solution
6. Contents of the pack and other information

1. What Betnovate 1 mg/g cutaneous solution is and what it is used for

It is a medicine containing betamethasone valerate as the active substance, which is a corticosteroid (anti-inflammatory). When applied to the scalp, it helps reduce redness, inflammation, and itching caused by certain scalp conditions.

Betnovate cutaneous solution is indicated for the treatment of inflammatory and pruritic (itchy) manifestations of scalp conditions that respond to corticosteroids, such as a scaly red condition often covered with silvery scales (psoriasis) and a rash with inflammation and scaling (seborrheic dermatitis).

Betnovate 1 mg/g cutaneous solution is indicated in adults and children over 12 years of age.

2. What you need to know before using Betnovate 1 mg/g cutaneous solution

Do not use Betnovate cutaneous solution:

• If you are allergic to betamethasone or to any of the other ingredients of this medicine (listed in section 6).
• If you have a fungal infection anywhere on the body or scalp (see next section).
• If you have bacterial or viral infections (for example: herpes or chickenpox).
• In skin diseases associated with thinning of the skin (atrophy).
• In ulcers, eyes, deep wounds, or acne.
• In children under 12 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Betnovate cutaneous solution.

• If irritation or local sensitivity occurs during use of the medicine, treatment should be discontinued and you should consult your doctor.
• If you develop an infection during treatment, consult your doctor regarding your treatment.
• When using topical corticosteroids, any of the adverse effects reported with corticosteroids administered by other routes may occur, such as disturbances in the function of glands located near the kidneys, leading to symptoms such as obesity, growth retardation, etc. (Cushing's syndrome), especially in children.
• Corticosteroids, such as the active ingredient in this medicine, have significant effects on the body. Betnovate should not be used over large areas of the body or for prolonged periods, as this significantly increases the risk of adverse effects.
• This medicine must not enter the eyes, open wounds, or mucous membranes (e.g., nose or mouth).
• If you are being treated for psoriasis, strict medical supervision of your condition is recommended to monitor for possible worsening.
• The treated scalp area should not be bandaged or covered unless instructed by your doctor, as this enhances penetration of the active ingredient through the skin and increases the risk of infection.
• Betnovate cutaneous solution is flammable (it can catch fire). Keep away from heat, fire, and flames. Do not smoke while applying or immediately after applying the medicine. Do not use a hair dryer after applying Betnovate cutaneous solution.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

This medicine is contraindicated in children under 12 years of age.

Use of Betnovate cutaneous solution with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No interactions between Betnovate cutaneous solution and other medicines are known. However, long-term treatment with corticosteroids could lead to interactions similar to those observed with systemic corticosteroid therapy due to absorption.

Pregnancy, breast-feeding, and fertility

If you are pregnant, breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Pregnancy

As a general rule, Betnovate cutaneous solution should not be used during the first trimester of pregnancy.

This medicine should not be used during pregnancy unless your doctor considers that the potential benefit justifies the potential risk to the fetus.

Pregnant women or those planning to become pregnant should not use Betnovate cutaneous solution over large areas of skin, in large amounts, or for prolonged periods, nor should they use occlusive dressings.

Breast-feeding

During breast-feeding, use of Betnovate may be considered if the expected benefit to the mother outweighs the potential risk to the infant.

Driving and using machines

Treatment with Betnovate does not affect the ability to drive or operate machinery.

3. How to use Betnovate 1 mg/g cutaneous solution

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Adults and children over 12 years of age:

Use Betnovate cutaneous solution once or twice daily on the affected area of the scalp, in the morning and at night. The frequency of application may be reduced depending on improvement.

Treatment may then be maintained by applying once daily,
or less frequently (on alternate days, for example).

The duration of treatment should not exceed 2 consecutive weeks at the maximum dose (twice daily).

Instructions for application:

• Open the bottle of solution and place the nozzle directly onto the area of scalp to be treated.
• Gently press the bottle to apply the product directly onto the scalp, covering the entire affected area with a thin layer of liquid. You may spread it gently with light massage, or not.
• You will feel a slight cooling sensation until the liquid dries.

If you wash your hair, apply Betnovate cutaneous solution after drying it.

Betnovate cutaneous solution is flammable. Keep away from heat, fire, or flames, and do not smoke while applying the product or after application. Do not dry your hair with a hair dryer after using Betnovate cutaneous solution.

Use in children and adolescents

Betnovate cutaneous solution is contraindicated in children under 12 years of age.

If you use more Betnovate cutaneous solution than you should

Excessive use of topical corticosteroids (repeated overdosing) may cause adverse effects (see section 4). If more Betnovate cutaneous solution is applied than recommended, or if it is ingested in excess, you may experience adverse effects.

If the solution is used more frequently than recommended or applied over large areas of skin, it may be absorbed into the body and cause various disorders; in children, this may affect their growth and development.

In cases of chronic toxicity, it is recommended that corticosteroids be gradually withdrawn. Treatment of overdose is symptomatic. Acute symptoms caused by excessive use of corticosteroids are generally reversible.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, go to a medical center, or call the Toxicology Information Service. Tel.: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to use Betnovate cutaneous solution

Do not apply a double dose to make up for missed doses.

If you forget to apply the solution, apply the missed dose as soon as you remember, and then continue treatment as usual.

If you stop treatment with Betnovate cutaneous solution

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If a sufficient amount of the medicine is absorbed through the skin and enters the bloodstream, adverse effects affecting your skin and other parts of the body may occur.

If your skin lesions worsen or become inflamed during treatment, you may be allergic to the medicine, have an infection, or require different treatment. Stop treatment and consult your doctor.

Adverse effects that have been reported:

• Frequent (may affect up to 1 in 10 people):

  • Itching of the skin
  • Localised burning sensation on the skin

• Very rare (may affect up to 1 in 10,000 people):

Prolonged use of Betnovate cutaneous solution, or use under occlusive dressings, may cause the following effects:

• Thinning of the skin (atrophy)

• Stretch marks

• Dryness of the skin

• Allergic skin reaction at the site of application (contact dermatitis)

• Appearance of blood vessels under the skin surface (telangiectasias)

• Acne

• Hair loss

• Increased body hair growth

• Changes in skin colour

• Pain or irritation at the site of application

• Worsening of skin lesions

• Redness

• Rash or hives

• Skin infection

• Rounded face

• Accumulation of fat in the neck area

• Delayed wound healing

• Psychiatric symptoms

• Obesity

• High blood pressure

• In children, the following very rare symptoms have also been observed:

  • Delayed weight gain and growth
  • Increased pressure inside the skull

• Adverse effects observed in blood tests or when the doctor requests an examination:

• Increased levels of blood sugar or glucose in urine, or increased cholesterol and other fats.

• Other adverse effects whose frequency is not exactly known:

• Cataracts (clouding of the lens)

• Glaucoma (increased intraocular pressure)

• Fungal infection of the skin or mucous membranes

• Specific skin inflammation around the upper lip and chin (perioral dermatitis)

• Inflammation of hair follicles

• Bruising

• Blurred vision

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Betnovate 1 mg/g Cutaneous Solution

Do not store above 25°C. Keep in the outer packaging to protect from light.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Package contents and other information

Composition of Betnovate cutaneous solution

• The active substance is betamethasone 17-valerate. Each g of cutaneous solution contains 1 mg of betamethasone 17-valerate (0.1 %).
• The other components (excipients) are: Carbomer, isopropyl alcohol, sodium hydroxide and purified water.

Appearance of the product and contents of the container

Betnovate 1 mg/g cutaneous solution is presented in a bottle with closure and cap.

Pack sizes: 30 g and 60 g.

Marketing Authorization Holder and Manufacturer

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

Local representative

NUTRICIÓN MÉDICA, S.L.

C/ Arequipa, 1

28043 Madrid

Date of the most recent review of this leaflet: September 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.